MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION; APICAL HOLE PLUG

Model Number AP-38016-04M

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

This investigation is on going.Once additional information is received, a supplemental mdr will be submitted accordingly.

Event Description

It was reported on (b)(6) 2023, during a my3d personalized pelvic reconstruction case, that the surgeon had difficulty threading an apical hole plug into a pelvic implant.As the apical hole plug was not able to be implanted, the surgeon used bone wax to fill the hole in the pelvic implant.The procedure was completed sucessfully, and no adverse events were reported.This event will be reportable to the fda as a malfunction.

Manufacturer Narrative

It was reported by an onkos engineer that during a my3d personalized pelvic reconstruction case (case (b)(6)) on (b)(6) 2023, the apical hole plug was not able to thread into the pelvic implant.Due to this issue, bone wax was used to fill in the cavity.The procedure was able to be completed successfully with a less than 10-minute surgical delay.Device history records were reviewed for ap-38016-04m, lot 93122, and no issues were identified.No issues were identified related to sterilization or packaging/labelling of the part.It is possible that the surgical approach may have made it difficult to install the apical hole plug due to the difficult to reach trajectories.However, this cause could not be determined conclusively.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Type of Device: APICAL HOLE PLUG
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 17098848
• MDR Text Key: 316929601
• Report Number: 3013450937-2023-00093
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP-38016-04M
• Device Lot Number: 93122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male